Browse Drug Recalls
2,097 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 2,097 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Drug Safety Recalls
Browse 2,097 FDA drug recalls in NJ.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 6, 2020 | Desflurane, USP Liquid for Inhalation, 240 mL, Rx Only, Manufactured by: Sha... | DEFECTIVE CONTAINER: Desflurane Liquid for Inhalation 240 mL may be leaking. | Class III | eVenus Pharmaceutical Laboratories |
| Sep 28, 2020 | Fluocinonide Ointment USP 0.05%, packaged in: a) 15 gm tube, NDC 52565-0040-1... | Failed Impurities/Degradation - Out-of-specification results for Fluocinolone Acetonide impurity. | Class III | Teligent Pharma, Inc. |
| Sep 23, 2020 | RIOMET ER (metformin hydrochloride for extended-release oral suspension), 500... | CGMP Deviations: Detection of N-nitrosodimethylamine (NDMA) impurity in finished drug product. | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Sep 4, 2020 | Buprenorphine Transdermal System 5 mcg/hour, 4 transdermal systems/4 disposal... | Failed Stability Specifications: Below specification result for buprenorphine release rate. | Class II | Teva Pharmaceuticals USA |
| Aug 24, 2020 | Strides Pharma Inc.Potassium Chloride Extended-Release Tablets, USP 8mEq (6... | Failed Dissolution Specifications | Class II | Strides Inc. |
| Aug 24, 2020 | Cephalexin for Oral Suspension, USP 250 mg per 5 mL, For Reconstitution, For ... | Sub-Potent Drug: Out of specification test results for potency (below specification). | Class II | Teva Pharmaceuticals USA |
| Aug 24, 2020 | Cephalexin for Oral Suspension, USP 125 mg per 5 mL, For Reconstitution, For ... | CGMP deviations; there is a possibility that some bottles in these lots may have the active ingre... | Class II | Teva Pharmaceuticals USA |
| Aug 24, 2020 | Cephalexin for Oral Suspension, USP 250 mg per 5 mL, For Reconstitution, For ... | CGMP deviations; there is a possibility that some bottles in these lots may have the active ingre... | Class II | Teva Pharmaceuticals USA |
| Aug 19, 2020 | Metformin Hydrochloride Extended-Release Tablets USP, 500 mg 1000 Tablets Rx ... | CGMP Deviations | Class II | BAYSHORE PHARMACEUTICALS |
| Aug 19, 2020 | Metformin Hydrochloride Extended-Release Tablets USP, 750 mg 100 Tablets Rx O... | CGMP Deviations | Class II | BAYSHORE PHARMACEUTICALS |
| Aug 14, 2020 | Buprenorphine HCl Injection, 0.3 mg/mL, 1 mL vial, For Intramuscular or Intra... | Sub-potent Drug: Out-of-Specification assay results found at 3 month stability testing. | Class II | Hikma Pharmaceuticals USA Inc. |
| Aug 10, 2020 | Sulfamethoxazole and Trimethoprim Tablets, USP, 800 mg/160 mg Double Strength... | Presence of Foreign Substance: product complaints were received by the firm for the presence of m... | Class II | Aurobindo Pharma USA Inc. |
| Aug 10, 2020 | Elitek (rasburicase) for injection, 7.5 mg vial, Rx Only Mfd. by Sanofi - Ave... | Failed Stability Specifications: Out of Specification result for enzyme activity levels noted dur... | Class II | Sanofi-Aventis U.S. LLC |
| Jul 21, 2020 | DDAVP Nasal Spray (desmopressin acetate) 10 mcg/0.1 mL, 5 mL bottles, Rx Only... | Superpotent Drug | Class I | Ferring Pharmaceuticals Inc |
| Jul 21, 2020 | Desmopressin Acetate Nasal Spray 10 mcg/0.1 mL, 5mL glass vial with spray cap... | Superpotent Drug | Class I | Ferring Pharmaceuticals Inc |
| Jul 21, 2020 | STIMATE (desmopressin acetate) Nasal Spray1.5 mg/mL, 2.5 mL glass vial with s... | Superpotent Drug | Class I | Ferring Pharmaceuticals Inc |
| Jul 14, 2020 | Lidocaine Patch 5%, packaged in 30-count cartons, Rx only, Manufactured by: A... | Labeling: Incorrect or Missing Lot and/or Exp date on the individual transdermal pouches but not ... | Class II | Teva Pharmaceuticals USA |
| Jul 13, 2020 | Hydrocortisone butyrate Cream, 0.1%, 15-gram tubes, Rx Only, Manufactured for... | SUBPOTENT DRUG | Class II | Bausch Health Companies, Inc. |
| Jul 6, 2020 | Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, 60-count bottle, Rx ... | Cross contamination with other products - OOS discovered during routine stability testing for hig... | Class III | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jun 16, 2020 | Childrens Robitussin Honey Cough and Chest Congestion DM, dextromethorphan (c... | Defective Delivery System: the dosing cups are missing graduations applicable to certain age groups. | Class II | Glaxosmithkline Consumer Healthcare Holdings |
| Jun 16, 2020 | Childrens Dimetapp Cold & Cough, For ages 6 yrs. & over, 8 FL OZ. bottle, (23... | Defective Delivery System: the dosing cups are missing graduations applicable to certain age groups. | Class II | Glaxosmithkline Consumer Healthcare Holdings |
| Jun 12, 2020 | Clozapine Tablets USP tablet, 100mg, 500-count bottle, Rx only, Distributed b... | Presence of foreign tablet: Consumer complaint of Clozapine Tablets 50mg being present in 500 cou... | Class II | Aurobindo Pharma USA Inc. |
| Jun 11, 2020 | Irinotecan HCL Injection, USP, 100mg/5mL, 5 mL vials, Rx only, Manufactured b... | Defective Container: Customer complaints received of a crimp defect while removing the flip-cap d... | Class II | Hikma Pharmaceuticals USA Inc. |
| Jun 11, 2020 | Irinotecan HCL Injection, USP, 100mg/5mL, 5 mL vials, Rx only, Manufactured b... | Defective Container: Customer complaints received of a crimp defect while removing the flip-cap d... | Class II | Hikma Pharmaceuticals USA Inc. |
| Jun 4, 2020 | Brimonidine Tartrate Opthalmic Solution 0.2%, 5 mL bottle, Rx only, Manufactu... | Failed Impurities/Degradation Specification: There is a slow leaching process from the product l... | Class III | SOMERSET THERAPEUTICS LLC |
| Jun 4, 2020 | Brimonidine Tartrate Opthalmic Solution 0.2%, 15 mL bottle, Rx only, Manufact... | Failed Impurities/Degradation Specification: There is a slow leaching process from the product l... | Class III | SOMERSET THERAPEUTICS LLC |
| Jun 4, 2020 | Brimonidine Tartrate Opthalmic Solution 0.2%, 10 mL bottle, Rx only, Manufact... | Failed Impurities/Degradation Specification: There is a slow leaching process from the product l... | Class III | SOMERSET THERAPEUTICS LLC |
| Jun 3, 2020 | Soft Whisper by Powerstick Dandruff Shampoo (Pyrithione Zinc), 14.4 FL OZ. (4... | cGMP Deviations: Soft Whisper Dandruff Shampoo was produced with water that failed USP specificat... | Class II | A.P. Deauville, LLC |
| Jun 2, 2020 | Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, a) 100 (NDC 620... | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... | Class II | Teva Pharmaceuticals USA |
| Jun 2, 2020 | Metformin Hydrochloride Extended - Release Tablets, USP, 500 mg, a) 100 (NDC ... | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... | Class II | Teva Pharmaceuticals USA |
| May 28, 2020 | Gaviscon Regular Strength Liquid Antacid Cool Mint, 6 FL OZ (177 mL), Distrib... | Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle la... | Class II | Glaxosmithkline Consumer Healthcare Holdings |
| May 28, 2020 | Gaviscon Liquid Antacid Extra Strength, Cool Mint, 12 FL OZ (355 mL) single p... | Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle la... | Class II | Glaxosmithkline Consumer Healthcare Holdings |
| May 28, 2020 | Gaviscon Extra Strength Liquid Antacid Extra Strength Cherry, 12 FL OZ. (355 ... | Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle la... | Class II | Glaxosmithkline Consumer Healthcare Holdings |
| May 28, 2020 | Gaviscon Regular Strength Liquid Antacid Cool Mint, 12 FL OZ (355 mL), Distri... | Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle la... | Class II | Glaxosmithkline Consumer Healthcare Holdings |
| May 26, 2020 | Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx only, Manufactured for: P... | Failed Impurities/ Degradation Specifications | Class III | Aurobindo Pharma USA Inc. |
| May 26, 2020 | Clonidine Hydrochloride Tablets, USP 0.1 mg 100-count bottles, Rx only, Manuf... | Failed Impurities/Degradation Specifications: potential migration of benzophenone at very low lev... | Class III | UNICHEM PHARMACEUTICALS USA INC |
| May 26, 2020 | Olanzapine Tablets, USP 7.5 mg, 30-count bottle, Rx only, Manufactured for: P... | Failed Impurities/ Degradation Specifications | Class III | Aurobindo Pharma USA Inc. |
| May 22, 2020 | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfat... | Some bottles may contain mixed strengths of the product. | Class II | Teva Pharmaceuticals USA |
| May 22, 2020 | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfat... | Some bottles may contain mixed strengths of the product. | Class II | Teva Pharmaceuticals USA |
| May 22, 2020 | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfat... | Some bottles may contain mixed strengths of the product. | Class II | Teva Pharmaceuticals USA |
| May 11, 2020 | Carbamazepine Tablets, USP 200 mg, packaged in a 500-count bottle, Rx only, M... | Failed Dissolution Specifications | Class II | Torrent Pharma Inc. |
| Apr 24, 2020 | Esomeprazole Magnesium Delayed Release Capsules USP, 40 mg*, 1000-count bott... | Discoloration: product contains brown pellets | Class III | Dr. Reddy's Laboratories, Inc. |
| Apr 21, 2020 | Infuvite PEDiatric Pharmacy, kit in 1 carton (40 mL fill in a 50 mL) vial 1... | Defective Container: Sub-optimal crimping in vial of Pediatric Infuvite Multiple Vitamins | Class II | Sandoz, Inc |
| Apr 20, 2020 | ChapStick Total Hydration Moisture + Tint + SPF15 Peachy Keen Net Wt. 0.08 OZ... | Labeling: Not elsewhere classified: Observed separation in the secondary packaging in the blister... | Class III | Glaxosmithkline Consumer Healthcare Holdings |
| Apr 20, 2020 | ChapStick Total Hydration Moisture + Tint + SPF15 Pretty in Pink Net Wt. 0.08... | Labeling: Not elsewhere classified: Observed separation in the secondary packaging in the blister... | Class III | Glaxosmithkline Consumer Healthcare Holdings |
| Apr 20, 2020 | ChapStick Total Hydration Moisture + Tint + SPF15 Very Berry Net Wt. 0.08 OZ... | Labeling: Not elsewhere classified: Observed separation in the secondary packaging in the blister... | Class III | Glaxosmithkline Consumer Healthcare Holdings |
| Mar 26, 2020 | Losartan Potassium Tablets USP 50 mg, a) 30 count (NDC 23155-645-03), b) 90 c... | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... | Class II | Avet Pharmaceuticals, Inc. |
| Mar 26, 2020 | Losartan Potassium Tablets USP 100 mg, supplied in a) 30 count (NDC 23155-646... | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... | Class II | Avet Pharmaceuticals, Inc. |
| Mar 25, 2020 | LOSARTAN POTASSIUM TABLETS, USP 25 mg, Bulk, Rx only, For Further Manufacturi... | CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the activ... | Class II | Teva Pharmaceuticals USA |
| Mar 25, 2020 | LOSARTAN POTASSIUM TABLETS, USP 100 mg, Bulk, Rx only, For Further Manufactur... | CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the activ... | Class II | Teva Pharmaceuticals USA |
Frequently Asked Questions
When a drug safety issue is identified — through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks — the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.
The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.
Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.